Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Medical Specialties (1099)
- Medical Sciences (558)
- Life Sciences (511)
- Oncology (403)
- Biomedical Informatics (384)
-
- Bioinformatics (373)
- COVID-19 (360)
- Diseases (244)
- Social and Behavioral Sciences (207)
- Women's Health (191)
- Obstetrics and Gynecology (189)
- Medical Genetics (175)
- Epidemiology (170)
- Mental and Social Health (159)
- Internal Medicine (157)
- Community Health and Preventive Medicine (136)
- Sociology (136)
- Maternal and Child Health (132)
- Genetic Phenomena (106)
- Race and Ethnicity (103)
- Pediatrics (98)
- Endocrinology, Diabetes, and Metabolism (87)
- Cardiology (79)
- Genetics and Genomics (78)
- Health and Medical Physics (78)
- Clinical Epidemiology (69)
- Public Health Education and Promotion (65)
- Neurology (62)
- Keyword
-
- Humans (1685)
- Female (840)
- Male (637)
- Adult (422)
- COVID-19 (382)
-
- Middle Aged (379)
- Aged (311)
- United States (246)
- SARS-CoV-2 (211)
- Adolescent (168)
- Risk Factors (162)
- Cross-Sectional Studies (156)
- Child (154)
- Retrospective Studies (137)
- Genome-Wide Association Study (127)
- Young Adult (127)
- Texas (122)
- Prospective Studies (121)
- Pregnancy (119)
- Infant (112)
- Animals (107)
- Pandemics (107)
- Cohort Studies (97)
- 80 and over (90)
- Aged, 80 and over (87)
- Diabetes Mellitus (86)
- Neoplasms (84)
- Polymorphism (82)
- Polymorphism, Single Nucleotide (81)
- Infant, Newborn (80)
Articles 1261 - 1290 of 2331
Full-Text Articles in Public Health
Integrative Prognostic Machine Learning Models In Mantle Cell Lymphoma, Holly A Hill, Preetesh Jain, Chi Young Ok, Koji Sasaki, Han Chen, Michael L Wang, Ken Chen
Integrative Prognostic Machine Learning Models In Mantle Cell Lymphoma, Holly A Hill, Preetesh Jain, Chi Young Ok, Koji Sasaki, Han Chen, Michael L Wang, Ken Chen
Faculty, Staff and Student Publications
Patients with mantle cell lymphoma (MCL), an incurable B-cell malignancy, benefit from accurate pretreatment disease stratification. We curated an extensive database of 862 patients diagnosed between 2014 and 2022. A machine learning (ML) gradient-boosted model incorporated baseline features from clinicopathologic, cytogenetic, and genomic data with high predictive power discriminating between patients with indolent or responsive MCL and those with aggressive disease (AUC ROC = 0.83). In addition, we utilized the gradient-boosted framework as a robust feature selection method for multivariate logistic and survival modeling. The best ML models incorporated features from clinical and genomic data types highlighting the need for …
Polypharmacy And Prescription Medication Use In A Population-Based Sample Of Adolescent And Young Adult Cancer Survivors, Andrea C Betts, Caitlin C Murphy, L Aubree Shay, Bijal A Balasubramanian, Christine Markham, Marlyn Allicock
Polypharmacy And Prescription Medication Use In A Population-Based Sample Of Adolescent And Young Adult Cancer Survivors, Andrea C Betts, Caitlin C Murphy, L Aubree Shay, Bijal A Balasubramanian, Christine Markham, Marlyn Allicock
Faculty, Staff and Student Publications
PURPOSE: We examined prescription medication use and identified correlates of polypharmacy-taking multiple medications-in adolescent and young adult cancer survivors (AYAs), who experience early-onset chronic conditions.
METHODS: Our cross-sectional study pooled data (2008-2017) from the national Medical Expenditure Panel Survey. We estimated prevalence of polypharmacy (≥ 5 unique prescription medications over an approximate 1-year period) in AYAs (age 18-39 years with a history of cancer) and age- and sex-matched controls, overall and by sociodemographics, clinical factors, and health indicators. We compared survivors' and controls' medication use across therapeutic classes. To identify correlates of polypharmacy among AYAs, we included factors with p …
An Updated Report On The Prevalence Of Prior Cancer Among Persons Newly Diagnosed With Cancer In The Surveillance, Epidemiology, And End Results Program, Caitlin C Murphy, Guillermo A Tortolero, David E Gerber, Sandi L Pruitt
An Updated Report On The Prevalence Of Prior Cancer Among Persons Newly Diagnosed With Cancer In The Surveillance, Epidemiology, And End Results Program, Caitlin C Murphy, Guillermo A Tortolero, David E Gerber, Sandi L Pruitt
Faculty, Staff and Student Publications
This cohort study uses population-based data from the National Cancer Institute Surveillance, Epidemiology, and End Results program of cancer registries to estimate prevalence of prior cancer among adults diagnosed with an incident cancer in 2019.
Parent-Reported Clinical Utility Of Pediatric Genomic Sequencing, Hadley Stevens Smith, Bart S Ferket, Bruce D Gelb, Lucia Hindorff, Kathleen D Ferar, Mary E Norton, Nuriye Sahin-Hodoglugil, Anne Slavotinek, Kristen Hasmiller Lich, Jonathan S Berg, Heidi V Russell
Parent-Reported Clinical Utility Of Pediatric Genomic Sequencing, Hadley Stevens Smith, Bart S Ferket, Bruce D Gelb, Lucia Hindorff, Kathleen D Ferar, Mary E Norton, Nuriye Sahin-Hodoglugil, Anne Slavotinek, Kristen Hasmiller Lich, Jonathan S Berg, Heidi V Russell
Faculty, Staff and Student Publications
BACKGROUND AND OBJECTIVES: Genomic sequencing (GS) is increasingly used for diagnostic evaluation, yet follow-up care is not well understood. We assessed clinicians' recommendations after GS, parent-reported follow-up, and actions parents initiated in response to learning their child's GS results.
METHODS: We surveyed parents of children who received GS through the Clinical Sequencing Evidence Generating Research consortium ∼5 to 7 months after return of results. We compared the proportion of parents who reported discussing their child's result with a clinician, clinicians' recommendations, and parents' follow-up actions by GS result type using χ2 tests.
RESULTS: A total of 1188 respondents completed survey …
Effects Of Immunosuppressive Treatment On Patient Outcomes After Immune Checkpoint Inhibitor-Related Gastrointestinal Toxicity, Malek Shatila, Weijie Ma, Yantong Cui, Sidra Naz, Anusha S Thomas, Enrico N De Toni, Helga-Paula Török, Najib Ben Khaled, Mehmet Altan, Bryan Schneider, Yinghong Wang
Effects Of Immunosuppressive Treatment On Patient Outcomes After Immune Checkpoint Inhibitor-Related Gastrointestinal Toxicity, Malek Shatila, Weijie Ma, Yantong Cui, Sidra Naz, Anusha S Thomas, Enrico N De Toni, Helga-Paula Török, Najib Ben Khaled, Mehmet Altan, Bryan Schneider, Yinghong Wang
Faculty, Staff and Student Publications
Purpose: Immune checkpoint inhibitors (ICIs) are increasingly used in the treatment of certain cancers but cause immune-related adverse events (irAEs). Gastrointestinal irAEs may necessitate extended periods of steroid use and the initiation of selective immunosuppressive therapy (SIT) which could theoretically counteract the effect of ICIs. In this study, we aim to explore the impact of immunosuppression use and duration on cancer progression and progression-free survival (PFS).
Methods: This is a single-center retrospective review exploring cancer outcomes in patients taking ICIs who developed gastrointestinal irAEs within 1 year of ICI initiation. Cancer outcome and progression free survival (PFS) were measured and …
Ancestral Diversity In Lipoprotein(A) Studies Helps Address Evidence Gaps, Moa P Lee, Sofia F Dimos, Laura M Raffield, Zhe Wang, Anna F Ballou, Carolina G Downie, Christopher H Arehart, Adolfo Correa, Paul S De Vries, Zhaohui Du, Christopher R Gignoux, Penny Gordon-Larsen, Xiuqing Guo, Jeffrey Haessler, Annie Green Howard, Yao Hu, Helina Kassahun, Shia T Kent, J Antonio G Lopez, Keri L Monda, Kari E North, Ulrike Peters, Michael H Preuss, Stephen S Rich, Shannon L Rhodes, Jie Yao, Rina Yarosh, Michael Y Tsai, Jerome I Rotter, Charles L Kooperberg, Ruth J F Loos, Christie Ballantyne, Christy L Avery, Mariaelisa Graff
Ancestral Diversity In Lipoprotein(A) Studies Helps Address Evidence Gaps, Moa P Lee, Sofia F Dimos, Laura M Raffield, Zhe Wang, Anna F Ballou, Carolina G Downie, Christopher H Arehart, Adolfo Correa, Paul S De Vries, Zhaohui Du, Christopher R Gignoux, Penny Gordon-Larsen, Xiuqing Guo, Jeffrey Haessler, Annie Green Howard, Yao Hu, Helina Kassahun, Shia T Kent, J Antonio G Lopez, Keri L Monda, Kari E North, Ulrike Peters, Michael H Preuss, Stephen S Rich, Shannon L Rhodes, Jie Yao, Rina Yarosh, Michael Y Tsai, Jerome I Rotter, Charles L Kooperberg, Ruth J F Loos, Christie Ballantyne, Christy L Avery, Mariaelisa Graff
Faculty, Staff and Student Publications
INTRODUCTION: The independent and causal cardiovascular disease risk factor lipoprotein(a) (Lp(a)) is elevated in >1.5 billion individuals worldwide, but studies have prioritised European populations.
METHODS: Here, we examined how ancestrally diverse studies could clarify Lp(a)'s genetic architecture, inform efforts examining application of Lp(a) polygenic risk scores (PRS), enable causal inference and identify unexpected Lp(a) phenotypic effects using data from African (n=25 208), East Asian (n=2895), European (n=362 558), South Asian (n=8192) and Hispanic/Latino (n=8946) populations.
RESULTS: Fourteen genome-wide significant loci with numerous population specific signals of large effect were identified that enabled construction of Lp(a) PRS of moderate (R
CONCLUSIONS: …
Outcomes Of Induction Vs Prelabor Cesarean Delivery At <33 Weeks For Hypertensive Disorders Of Pregnancy, Elisa T Bushman, William A Grobman, Jennifer L Bailit, Uma M Reddy, Ronald J Wapner, Michael W Varner, John M Thorp, Steve N Caritis, Mona Prasad, George R Saade, Yoram Sorokin, Dwight J Rouse, Sean C Blackwell, Jorge E Tolosa
Outcomes Of Induction Vs Prelabor Cesarean Delivery At <33 Weeks For Hypertensive Disorders Of Pregnancy, Elisa T Bushman, William A Grobman, Jennifer L Bailit, Uma M Reddy, Ronald J Wapner, Michael W Varner, John M Thorp, Steve N Caritis, Mona Prasad, George R Saade, Yoram Sorokin, Dwight J Rouse, Sean C Blackwell, Jorge E Tolosa
Faculty, Staff and Student Publications
BACKGROUND: Hypertensive disorders of pregnancy are the leading cause of indicated preterm birth; however, the optimal delivery approach for pregnancies complicated by preterm hypertensive disorders of pregnancy remains uncertain.
OBJECTIVE: This study aimed to compare maternal and neonatal morbidity in patients with hypertensive disorders of pregnancy who either went induction of labor or prelabor cesarean delivery at <33 >weeks' gestation. In addition, we aimed to quantify the length of induction of labor and rate of vaginal delivery in those who underwent induction of labor.
STUDY DESIGN: This is a secondary analysis of an observational study which included 115,502 patients in 25 …
Do Vaccinations Influence The Development Of Alzheimer Disease?, Avram S Bukhbinder, Yaobin Ling, Kristofer Harris, Xiaoqian Jiang, Paul E Schulz
Do Vaccinations Influence The Development Of Alzheimer Disease?, Avram S Bukhbinder, Yaobin Ling, Kristofer Harris, Xiaoqian Jiang, Paul E Schulz
Faculty, Staff and Student Publications
A growing literature supports a protective association between vaccines targeting an array of pathogens (e.g., influenza, pneumococcus, herpes zoster) and the risk of Alzheimer disease (AD). This article discusses the potential underlying mechanisms for this apparent protective effect of immunizations against infectious pathogens on the risk of AD; explores the basic and pharmacoepidemiologic evidence for this association, with particular attention paid to important methodological variations among the epidemiologic studies; and reviews the remaining uncertainties regarding the effects of anti-pathogen vaccines on Alzheimer disease and all-cause dementia, with recommendations for future directions to address those uncertainties.
Postoperative Respiratory Complications In Sars-Cov-2 Positive Pediatric Patients Across 20 United States Hospitals: A Cohort Study, Audra J Reiter, Martha-Conley E Ingram, Mehul V Raval, Elisa Garcia, Madelyn Hill, Arturo Aranda, Nicole M Chandler, Raquel Gonzalez, Kristen Born, Shale Mack, Abdulraouf Lamoshi, Aaron M Lipskar, Xiao-Yue Han, Elizabeth Fialkowski, Brianna Spencer, Afif N Kulaylat, Amrene Barde, Ami N Shah, Maeva Adoumie, Erica Gross, Steven C Mehl, Monica E Lopez, Valerie Polcz, Moiz M Mustafa, Jeffrey W Gander, Travis M Sullivan, Jason P Sulkowski, Owais Ghani, Eunice Y Huang, David Rothstein, E Peter Muenks, Shawn D St Peter, Jason C Fisher, Dina Levy-Lambert, Allison Reichl, Romeo C Ignacio, Bethany J Slater, Kuojen Tsao, Loren Berman
Postoperative Respiratory Complications In Sars-Cov-2 Positive Pediatric Patients Across 20 United States Hospitals: A Cohort Study, Audra J Reiter, Martha-Conley E Ingram, Mehul V Raval, Elisa Garcia, Madelyn Hill, Arturo Aranda, Nicole M Chandler, Raquel Gonzalez, Kristen Born, Shale Mack, Abdulraouf Lamoshi, Aaron M Lipskar, Xiao-Yue Han, Elizabeth Fialkowski, Brianna Spencer, Afif N Kulaylat, Amrene Barde, Ami N Shah, Maeva Adoumie, Erica Gross, Steven C Mehl, Monica E Lopez, Valerie Polcz, Moiz M Mustafa, Jeffrey W Gander, Travis M Sullivan, Jason P Sulkowski, Owais Ghani, Eunice Y Huang, David Rothstein, E Peter Muenks, Shawn D St Peter, Jason C Fisher, Dina Levy-Lambert, Allison Reichl, Romeo C Ignacio, Bethany J Slater, Kuojen Tsao, Loren Berman
Faculty, Staff and Student Publications
INTRODUCTION: Data examining rates of postoperative complications among SARS-CoV-2 positive children are limited. The purpose of this study was to evaluate the impact of symptomatic and asymptomatic SARS-CoV-2 positive status on postoperative respiratory outcomes for children.
METHODS: This retrospective cohort study included SARS-CoV-2 positive pediatric patients across 20 hospitals who underwent general anesthesia from March to October 2020. The primary outcome was frequency of postoperative respiratory complications, including: high-flow nasal cannula/non invasive ventilation, reintubation, pneumonia, Extracorporeal Membrane Oxygenation (ECMO), and 30-day respiratory-related readmissions or emergency department (ED) visits. Univariate analyses were used to evaluate associations between patient and procedure characteristics …
A Previously Healthy Infant With Lemierre Syndrome In The Emergency Department: Case Report, Adeola Adekunbi Kosoko, Omoyeni O Clement
A Previously Healthy Infant With Lemierre Syndrome In The Emergency Department: Case Report, Adeola Adekunbi Kosoko, Omoyeni O Clement
Faculty, Staff and Student Publications
INTRODUCTION: Lemierre syndrome (LS) is a rare condition with a high mortality risk. It is well described in older children and young adults involving bacteremia, thrombophlebitis, and metastatic abscess commonly due to Fusobacterium infections. Young, pre-verbal children are also susceptible to LS; thus, careful attention must be given to their pattern of symptoms and history to identify this condition in the emergency department (ED).
CASE REPORT: A 12-month-old previously healthy boy with a recent diagnosis of acute otitis media and viral illness presented to the ED with a complaint of fever. Additional symptoms developed at the head and neck and …
Who Is At Risk For New Hepatitis B Infections Among People With Hiv?, John M Sladic, Barbara S Taylor, Mae Thamer, Karen J Vigil, Onkar Kshirsagar, Anna Taranova, Andrew Mccracken, Carmen G Sanchez, Mamta K Jain
Who Is At Risk For New Hepatitis B Infections Among People With Hiv?, John M Sladic, Barbara S Taylor, Mae Thamer, Karen J Vigil, Onkar Kshirsagar, Anna Taranova, Andrew Mccracken, Carmen G Sanchez, Mamta K Jain
Faculty, Staff and Student Publications
Hepatitis B virus (HBV) increases morbidity and mortality among people with HIV (PWH). We retrospectively analyzed HBV incidence among 5785 PWH. Fourteen had newly positive hepatitis B s antigen (mean 5.2 person-years of follow-up, 46.4/100 000 infections/year). These data show gaps in HBV vaccination and in the preventative efficacy of HBV-specific antiretroviral therapy.
Individual, Systemic And State Factors Associated With Provider Recommendation Of Hpv Vaccination: Findings From Nis-Teen, 2020, Ikponmwosa Osaghae, Monalisa Chandra, Rajesh Talluri, Sanjay Shete
Individual, Systemic And State Factors Associated With Provider Recommendation Of Hpv Vaccination: Findings From Nis-Teen, 2020, Ikponmwosa Osaghae, Monalisa Chandra, Rajesh Talluri, Sanjay Shete
Faculty, Staff and Student Publications
The most important determinant of HPV vaccination uptake is healthcare provider recommendation, yet not all eligible patients receive HPV vaccination recommendations. We used data from the 2020 National Immunization Survey-Teen to determine individual, systemic, and state factors associated with provider recommendation of HPV vaccination. A total of 18,534 teens were included, with 81.4% receiving provider recommendations for HPV vaccination. HPV vaccination recommendation was higher among females compared to males (AOR: 1.57; 95% CI: 1.27-1.93), teens who received a well-child exam at 11 or 12 years compared to those who did not (AOR: 2.10; 95% CI: 1.61-2.74), and teens whose mothers …
Missense Genetic Variation Of Icam1 And Incident Heart Failure, Pedro Giro, Jonathan W Cunningham, Laura Rasmussen-Torvik, Suzette J Bielinski, Nicholas B Larson, Laura A Colangelo, David R Jacobs, Myron Gross, Alex P Reiner, Donald M Lloyd-Jones, Xiuqing Guo, Kent Taylor, Muthiah Vaduganathan, Wendy S Post, Alain Bertoni, Christie Ballantyne, Amil Shah, Brian Claggett, Eric Boerwinkle, Bing Yu, Scott D Solomon, Sanjiv J Shah, Ravi B Patel
Missense Genetic Variation Of Icam1 And Incident Heart Failure, Pedro Giro, Jonathan W Cunningham, Laura Rasmussen-Torvik, Suzette J Bielinski, Nicholas B Larson, Laura A Colangelo, David R Jacobs, Myron Gross, Alex P Reiner, Donald M Lloyd-Jones, Xiuqing Guo, Kent Taylor, Muthiah Vaduganathan, Wendy S Post, Alain Bertoni, Christie Ballantyne, Amil Shah, Brian Claggett, Eric Boerwinkle, Bing Yu, Scott D Solomon, Sanjiv J Shah, Ravi B Patel
Faculty, Staff and Student Publications
BACKGROUND: Intercellular adhesion molecule-1 (ICAM-1) is a cell surface protein that participates in endothelial activation and is hypothesized to play a central role in heart failure (HF). We evaluated associations of ICAM1 missense genetic variants with circulating ICAM-1 levels and with incident HF.
METHODS AND RESULTS: We identified 3 missense variants within ICAM1 (rs5491, rs5498 and rs1799969) and evaluated their associations with ICAM-1 levels in the Coronary Artery Risk Development in Young Adults Study and the Multi-Ethnic Study of Atherosclerosis (MESA). We determined the association among these 3 variants and incident HF in MESA. We separately evaluated significant associations in …
A Genome-Wide Association Study Identifies 41 Loci Associated With Eicosanoid Levels, Eugene P Rhee, Aditya L Surapaneni, Pascal Schlosser, Mona Alotaibi, Yueh-Ning Yang, Josef Coresh, Mohit Jain, Susan Cheng, Bing Yu, Morgan E Grams
A Genome-Wide Association Study Identifies 41 Loci Associated With Eicosanoid Levels, Eugene P Rhee, Aditya L Surapaneni, Pascal Schlosser, Mona Alotaibi, Yueh-Ning Yang, Josef Coresh, Mohit Jain, Susan Cheng, Bing Yu, Morgan E Grams
Faculty, Staff and Student Publications
Eicosanoids are biologically active derivatives of polyunsaturated fatty acids with broad relevance to health and disease. We report a genome-wide association study in 8406 participants of the Atherosclerosis Risk in Communities Study, identifying 41 loci associated with 92 eicosanoids and related metabolites. These findings highlight loci required for eicosanoid biosynthesis, including FADS1-3, ELOVL2, and numerous CYP450 loci. In addition, significant associations implicate a range of non-oxidative lipid metabolic processes in eicosanoid regulation, including at PKD2L1/SCD and several loci involved in fatty acyl-CoA metabolism. Further, our findings highlight select clearance mechanisms, for example, through the hepatic transporter encoded by SLCO1B1. Finally, …
Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly
Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly
Faculty, Staff and Student Publications
IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19.
OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and …
Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly, Activ-1 Im Study Group Members
Abatacept, Cenicriviroc, Or Infliximab For Treatment Of Adults Hospitalized With Covid-19 Pneumonia: A Randomized Clinical Trial, Jane A O'Halloran, Emily R Ko, Kevin J Anstrom, Eyal Kedar, Matthew W Mccarthy, Reynold A Panettieri, Martin Maillo, Patricia Segura Nunez, Anne M Lachiewicz, Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, Akram Khan, Alfredo J Mena Lora, Matthias Salathe, Gerardo Capo, Daniel Rodríguez Gonzalez, Thomas F Patterson, Christopher Palma, Horacio Ariza, Maria Patelli Lima, John Blamoun, Esteban C Nannini, Eduardo Sprinz, Analia Mykietiuk, Radica Alicic, Adriana M Rauseo, Cameron R Wolfe, Britta Witting, Jennifer P Wang, Luis Parra-Rodriguez, Tatyana Der, Kate Willsey, Jun Wen, Adam Silverstein, Sean M O'Brien, Hussein R Al-Khalidi, Michael A Maldonado, Richard Melsheimer, William G Ferguson, Steven E Mcnulty, Pearl Zakroysky, Susan Halabi, Daniel K Benjamin, Sandra Butler, Jane C Atkinson, Stacey J Adam, Soju Chang, Lisa Lavange, Michael Proschan, Samuel A Bozzette, William G Powderly, Activ-1 Im Study Group Members
Faculty, Staff and Student Publications
IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19.
OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and …
The Screening Of The Protective Antigens Of Aeromonas Hydrophila Using The Reverse Vaccinology Approach: Potential Candidates For Subunit Vaccine Development, Ting Zhang, Minying Zhang, Zehua Xu, Yang He, Xiaoheng Zhao, Hanliang Cheng, Xiangning Chen, Jianhe Xu, Zhujin Ding
The Screening Of The Protective Antigens Of Aeromonas Hydrophila Using The Reverse Vaccinology Approach: Potential Candidates For Subunit Vaccine Development, Ting Zhang, Minying Zhang, Zehua Xu, Yang He, Xiaoheng Zhao, Hanliang Cheng, Xiangning Chen, Jianhe Xu, Zhujin Ding
Faculty, Staff and Student Publications
The threat of bacterial septicemia caused by Aeromonas hydrophila infection to aquaculture growth can be prevented through vaccination, but differences among A. hydrophila strains may affect the effectiveness of non-conserved subunit vaccines or non-inactivated A. hydrophila vaccines, making the identification and development of conserved antigens crucial. In this study, a bioinformatics analysis of 4268 protein sequences encoded by the A. hydrophila J-1 strain whole genome was performed based on reverse vaccinology. The specific analysis included signal peptide prediction, transmembrane helical structure prediction, subcellular localization prediction, and antigenicity and adhesion evaluation, as well as interspecific and intraspecific homology comparison, thereby screening …
Targeting Polyploid Giant Cancer Cells Potentiates A Therapeutic Response And Overcomes Resistance To Parp Inhibitors In Ovarian Cancer, Xudong Zhang, Jun Yao, Xiaoran Li, Na Niu, Yan Liu, Richard A Hajek, Guang Peng, Shannon Westin, Anil K Sood, Jinsong Liu
Targeting Polyploid Giant Cancer Cells Potentiates A Therapeutic Response And Overcomes Resistance To Parp Inhibitors In Ovarian Cancer, Xudong Zhang, Jun Yao, Xiaoran Li, Na Niu, Yan Liu, Richard A Hajek, Guang Peng, Shannon Westin, Anil K Sood, Jinsong Liu
Faculty, Staff and Student Publications
To understand the mechanism of acquired resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) olaparib, we induced the formation of polyploid giant cancer cells (PGCCs) in ovarian and breast cancer cell lines, high-grade serous cancer (HGSC)-derived organoids, and patient-derived xenografts (PDXs). Time-lapse tracking of ovarian cancer cells revealed that PGCCs primarily developed from endoreplication after exposure to sublethal concentrations of olaparib. PGCCs exhibited features of senescent cells but, after olaparib withdrawal, can escape senescence via restitutional multipolar endomitosis and other noncanonical modes of cell division to generate mitotically competent resistant daughter cells. The contraceptive drug mifepristone blocked PGCC formation and daughter cell …
Adaptation And Formative Evaluation Of Online Decision Support To Implement Evidence-Based Strategies To Increase Hpv Vaccination Rates In Pediatric Clinics, Ross Shegog, Lara S Savas, Erica L Frost, Laura C Thormaehlen, Travis Teague, Jack Steffy, Catherine Mary Healy, Laura Aubree Shay, Sharice Preston, Sally W Vernon
Adaptation And Formative Evaluation Of Online Decision Support To Implement Evidence-Based Strategies To Increase Hpv Vaccination Rates In Pediatric Clinics, Ross Shegog, Lara S Savas, Erica L Frost, Laura C Thormaehlen, Travis Teague, Jack Steffy, Catherine Mary Healy, Laura Aubree Shay, Sharice Preston, Sally W Vernon
Faculty, Staff and Student Publications
Human papilloma virus (HPV) vaccination rates remain below national goals in the United States despite the availability of evidence-based strategies to increase rates. The Adolescent Vaccination Program (AVP) is a multi-component intervention demonstrated to increase HPV vaccination rates in pediatric clinics through the implementation of six evidence-based strategies. The purpose of this study, conducted in Houston, Texas, from 2019-2021, was to adapt the AVP into an online decision support implementation tool for standalone use and to evaluate its feasibility for use in community clinics. Phase 1 (Adaptation) comprised clinic interviews (
Efficacy And Safety Of Elamipretide In Individuals With Primary Mitochondrial Myopathy: The Mmpower-3 Randomized Clinical Trial, Amel Karaa, Enrico Bertini, Valerio Carelli, Bruce H Cohen, Gregory M Enns, Marni J Falk, Amy Goldstein, Gráinne Siobhan Gorman, Richard Haas, Michio Hirano, Thomas Klopstock, Mary Kay Koenig, Cornelia Kornblum, Costanza Lamperti, Anna Lehman, Nicola Longo, Maria Judit Molnar, Sumit Parikh, Han Phan, Robert D S Pitceathly, Russell Saneto, Fernando Scaglia, Serenella Servidei, Mark Tarnopolsky, Antonio Toscano, Johan L K Van Hove, John Vissing, Jerry Vockley, Jeffrey S Finman, David A Brown, James A Shiffer, Michelango Mancuso, Mmpower-3 Trial Investigators
Efficacy And Safety Of Elamipretide In Individuals With Primary Mitochondrial Myopathy: The Mmpower-3 Randomized Clinical Trial, Amel Karaa, Enrico Bertini, Valerio Carelli, Bruce H Cohen, Gregory M Enns, Marni J Falk, Amy Goldstein, Gráinne Siobhan Gorman, Richard Haas, Michio Hirano, Thomas Klopstock, Mary Kay Koenig, Cornelia Kornblum, Costanza Lamperti, Anna Lehman, Nicola Longo, Maria Judit Molnar, Sumit Parikh, Han Phan, Robert D S Pitceathly, Russell Saneto, Fernando Scaglia, Serenella Servidei, Mark Tarnopolsky, Antonio Toscano, Johan L K Van Hove, John Vissing, Jerry Vockley, Jeffrey S Finman, David A Brown, James A Shiffer, Michelango Mancuso, Mmpower-3 Trial Investigators
Faculty, Staff and Student Publications
BACKGROUND AND OBJECTIVES: Primary mitochondrial myopathies (PMMs) encompass a group of genetic disorders that impair mitochondrial oxidative phosphorylation, adversely affecting physical function, exercise capacity, and quality of life (QoL). Current PMM standards of care address symptoms, with limited clinical impact, constituting a significant therapeutic unmet need. We present data from MMPOWER-3, a pivotal, phase-3, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of elamipretide in participants with genetically confirmed PMM.
METHODS: After screening, eligible participants were randomized 1:1 to receive either 24 weeks of elamipretide at a dose of 40 mg/d or placebo subcutaneously. Primary efficacy endpoints …
Integrating Genetics And Metabolomics From Multi-Ethnic And Multi-Fluid Data Reveals Putative Mechanisms For Age-Related Macular Degeneration, Xikun Han, Ines Lains, Jun Li, Jinglun Li, Yiheng Chen, Bing Yu, Qibin Qi, Eric Boerwinkle, Robert Kaplan, Bharat Thyagarajan, Martha Daviglus, Charlotte E Joslin, Jianwen Cai, Marta Guasch-Ferré, Deirdre K Tobias, Eric Rimm, Alberto Ascherio, Karen Costenbader, Elizabeth Karlson, Lorelei Mucci, A Heather Eliassen, Oana Zeleznik, John Miller, Demetrios G Vavvas, Ivana K Kim, Rufino Silva, Joan Miller, Frank Hu, Walter Willett, Jessica Lasky-Su, Peter Kraft, J Brent Richards, Stuart Macgregor, Deeba Husain, Liming Liang
Integrating Genetics And Metabolomics From Multi-Ethnic And Multi-Fluid Data Reveals Putative Mechanisms For Age-Related Macular Degeneration, Xikun Han, Ines Lains, Jun Li, Jinglun Li, Yiheng Chen, Bing Yu, Qibin Qi, Eric Boerwinkle, Robert Kaplan, Bharat Thyagarajan, Martha Daviglus, Charlotte E Joslin, Jianwen Cai, Marta Guasch-Ferré, Deirdre K Tobias, Eric Rimm, Alberto Ascherio, Karen Costenbader, Elizabeth Karlson, Lorelei Mucci, A Heather Eliassen, Oana Zeleznik, John Miller, Demetrios G Vavvas, Ivana K Kim, Rufino Silva, Joan Miller, Frank Hu, Walter Willett, Jessica Lasky-Su, Peter Kraft, J Brent Richards, Stuart Macgregor, Deeba Husain, Liming Liang
Faculty, Staff and Student Publications
Age-related macular degeneration (AMD) is a leading cause of blindness in older adults. Investigating shared genetic components between metabolites and AMD can enhance our understanding of its pathogenesis. We conduct metabolite genome-wide association studies (mGWASs) using multi-ethnic genetic and metabolomic data from up to 28,000 participants. With bidirectional Mendelian randomization analysis involving 16,144 advanced AMD cases and 17,832 controls, we identify 108 putatively causal relationships between plasma metabolites and advanced AMD. These metabolites are enriched in glycerophospholipid metabolism, lysophospholipid, triradylcglycerol, and long chain polyunsaturated fatty acid pathways. Bayesian genetic colocalization analysis and a customized metabolome-wide association approach prioritize putative causal …
Women With Large Vessel Occlusion Acute Ischemic Stroke Are Less Likely To Be Routed To Comprehensive Stroke Centers, Muhammad Bilal Tariq, Iman Ali, Sergio Salazar-Marioni, Ananya S Iyyangar, Hussain M Azeem, Swapnil Khose, Victor Lopez, Rania Abdelkhaleq, Louise D Mccullough, Sunil A Sheth, Youngran Kim
Women With Large Vessel Occlusion Acute Ischemic Stroke Are Less Likely To Be Routed To Comprehensive Stroke Centers, Muhammad Bilal Tariq, Iman Ali, Sergio Salazar-Marioni, Ananya S Iyyangar, Hussain M Azeem, Swapnil Khose, Victor Lopez, Rania Abdelkhaleq, Louise D Mccullough, Sunil A Sheth, Youngran Kim
Faculty, Staff and Student Publications
Background Prehospital routing of patients with large vessel occlusion (LVO) acute ischemic stroke (AIS) to centers capable of performing endovascular therapy may improve clinical outcomes. Here, we explore whether distance to comprehensive stroke centers (CSCs), stroke severity, and sex are associated with direct-to-CSC prehospital routing in patients with LVO AIS. Methods and Results In this cross-sectional study, we identified consecutive patients with LVO AIS from a prospectively collected multihospital registry throughout the greater Houston area from January 2019 to June 2020. Primary outcome was prehospital routing to CSC and was compared between men and women using modified Poisson regression including …
Psychosocial Impacts Of The Covid-19 Pandemic On Women With Spinal Cord Injury, Heather B Taylor, Rosemary B Hughes, Diana Gonzalez, Muna Bhattarai, Susan Robinson-Whelen
Psychosocial Impacts Of The Covid-19 Pandemic On Women With Spinal Cord Injury, Heather B Taylor, Rosemary B Hughes, Diana Gonzalez, Muna Bhattarai, Susan Robinson-Whelen
Faculty, Staff and Student Publications
This study represents the first known research addressing the impact of the COVID-19 pandemic on women with spinal cord injury (SCI) in the United States. Women in this population face unique barriers that put them at elevated risk for compromised quality of life, risk that was magnified by physical and social restrictions imposed during the pandemic. This qualitative study examined the perceptions of women with SCI and the effect of the pandemic on their lives. The predominantly White and relatively well-educated sample of 105 women with traumatic SCI was diverse in age, injury characteristics, and geographic representation. Recruited across the …
Ancestry-Driven Metabolite Variation Provides Insights Into Disease States In Admixed Populations, Kaylia M Reynolds, Andrea R V R Horimoto, Bridget M Lin, Ying Zhang, Nuzulul Kurniansyah, Bing Yu, Eric Boerwinkle, Qibin Qi, Robert Kaplan, Martha Daviglus, Lifang Hou, Laura Y Zhou, Jianwen Cai, Saame Raza Shaikh, Tamar Sofer, Sharon R Browning, Nora Franceschini
Ancestry-Driven Metabolite Variation Provides Insights Into Disease States In Admixed Populations, Kaylia M Reynolds, Andrea R V R Horimoto, Bridget M Lin, Ying Zhang, Nuzulul Kurniansyah, Bing Yu, Eric Boerwinkle, Qibin Qi, Robert Kaplan, Martha Daviglus, Lifang Hou, Laura Y Zhou, Jianwen Cai, Saame Raza Shaikh, Tamar Sofer, Sharon R Browning, Nora Franceschini
Faculty, Staff and Student Publications
BACKGROUND: Metabolic pathways are related to physiological functions and disease states and are influenced by genetic variation and environmental factors. Hispanics/Latino individuals have ancestry-derived genomic regions (local ancestry) from their recent admixture that have been less characterized for associations with metabolite abundance and disease risk.
METHODS: We performed admixture mapping of 640 circulating metabolites in 3887 Hispanic/Latino individuals from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Metabolites were quantified in fasting serum through non-targeted mass spectrometry (MS) analysis using ultra-performance liquid chromatography-MS/MS. Replication was performed in 1856 nonoverlapping HCHS/SOL participants with metabolomic data.
RESULTS: By leveraging local ancestry, this …
Analysis Of Performance And Failure Modes Of The Iroc Proton Liver Phantom, Hunter Mehrens, Paige Taylor, Paola Alvarez, Stephen Kry
Analysis Of Performance And Failure Modes Of The Iroc Proton Liver Phantom, Hunter Mehrens, Paige Taylor, Paola Alvarez, Stephen Kry
Faculty, Staff and Student Publications
Purpose: To analyze trends in institutional performance and failure modes for the Imaging and Radiation Oncology Core’s (IROC’s) proton liver phantom.
Materials and Methods: Results of 66 phantom irradiations from 28 institutions between 2015 and 2020 were retrospectively analyzed. Univariate analysis and random forest models were used to associate irradiation conditions with phantom results. Phantom results included pass/fail classification, average thermoluminescent dosimeter (TLD) ratio of both targets, and percentage of pixels passing gamma of both targets. The following categories were evaluated in terms of how they predicted these outcomes: irradiation year, treatment planning system (TPS), TPS algorithm, treatment machine, number …
An Observational Study To Develop A Predictive Model For Bacterial Pneumonia Diagnosis In Severe Covid-19 Patients-C19-Pneumoscore, Eloisa Sofia Tanzarella, Joel Vargas, Marco Menghini, Stefania Postorino, Francesca Pozzana, Maria Sole Vallecoccia, Francesco Lorenzo De Matteis, Federico Franchi, Amato Infante, Luigi Larosa, Maria Antonietta Mazzei, Salvatore Lucio Cutuli, Domenico Luca Grieco, Alessandra Bisanti, Simone Carelli, Gianmarco Lombardi, Edoardo Piervincenzi, Gabriele Pintaudi, Tommaso Pirronti, Mario Tumbarello, Massimo Antonelli, Gennaro De Pascale
An Observational Study To Develop A Predictive Model For Bacterial Pneumonia Diagnosis In Severe Covid-19 Patients-C19-Pneumoscore, Eloisa Sofia Tanzarella, Joel Vargas, Marco Menghini, Stefania Postorino, Francesca Pozzana, Maria Sole Vallecoccia, Francesco Lorenzo De Matteis, Federico Franchi, Amato Infante, Luigi Larosa, Maria Antonietta Mazzei, Salvatore Lucio Cutuli, Domenico Luca Grieco, Alessandra Bisanti, Simone Carelli, Gianmarco Lombardi, Edoardo Piervincenzi, Gabriele Pintaudi, Tommaso Pirronti, Mario Tumbarello, Massimo Antonelli, Gennaro De Pascale
Faculty, Staff and Student Publications
In COVID-19 patients, antibiotics overuse is still an issue. A predictive scoring model for the diagnosis of bacterial pneumonia at intensive care unit (ICU) admission would be a useful stewardship tool. We performed a multicenter observational study including 331 COVID-19 patients requiring invasive mechanical ventilation at ICU admission; 179 patients with bacterial pneumonia; and 152 displaying negative lower-respiratory samplings. A multivariable logistic regression model was built to identify predictors of pulmonary co-infections, and a composite risk score was developed using β-coefficients. We identified seven variables as predictors of bacterial pneumonia: vaccination status (OR 7.01; 95% CI, 1.73-28.39); chronic kidney disease …
Determinants Of Covid-19 Vaccination Decision-Making Behaviors Among Pregnant Women In Sub-Saharan Africa: A Scoping Review, Sylvia Ayieko, Kimberly Baker, Sarah E Messiah, Brianna Lewis, Christine Markham
Determinants Of Covid-19 Vaccination Decision-Making Behaviors Among Pregnant Women In Sub-Saharan Africa: A Scoping Review, Sylvia Ayieko, Kimberly Baker, Sarah E Messiah, Brianna Lewis, Christine Markham
Faculty, Staff and Student Publications
Despite the availability of the coronavirus disease 2019 (COVID-19) vaccination, uptake among pregnant women in Sub-Saharan Africa has been low. This scoping review aimed to identify and characterize determinants influencing COVID-19 vaccination decision-making behaviors among pregnant women in Sub-Saharan Africa. We searched five online databases for articles on COVID-19 vaccination among pregnant women in Sub-Saharan Africa. We identified studies published in English between March 2020 and April 2023 that assessed vaccine-specific issues, psychosocial constructs, and contextual factors associated with COVID-19 vaccination decision-making behaviors. Of the fourteen studies identified, over half (57.1%) were cross-sectional; three used qualitative research methods; and three …
The Impact Of Covid-19 On The Financial Performance Of Largest Teaching Hospitals, Karima Lalani, Jeffrey Helton, Francine R Vega, Marylou Cardenas-Turanzas, Tiffany Champagne-Langabeer, James R Langabeer
The Impact Of Covid-19 On The Financial Performance Of Largest Teaching Hospitals, Karima Lalani, Jeffrey Helton, Francine R Vega, Marylou Cardenas-Turanzas, Tiffany Champagne-Langabeer, James R Langabeer
Faculty, Staff and Student Publications
The COVID-19 pandemic disrupted hospital operations. Anecdotal evidence suggests financial performance likewise suffered, yet little empirical research supports this claim. This study aimed to explore the impact of the pandemic on the financial performance of the most prominent academic hospitals in the United States. Data from the 115 largest major teaching hospitals in the United States were extracted from the American Hospital Directory for three years (2019-2021). We hypothesized that the year and region would moderate the relationship between a hospital's return on assets (financial performance) and specific operational variables. We found evidence through descriptive statistics and multivariate moderated regressions …
Effect Of Reduced Versus Usual Lipid Emulsion Dosing On Bilirubin Neurotoxicity And Neurodevelopmental Impairment In Extremely Preterm Infants: Study Protocol For A Randomized Controlled Trial, Lindsay F Holzapfel, Cody Arnold, Jon E Tyson, Steven M Shapiro, Eric W Reynolds, Claudia Pedroza, Emily K Stephens, Alan Kleinfeld, Andrew H Huber, Matthew A Rysavy, Maria Del Mar Romero Lopez, Amir M Khan
Effect Of Reduced Versus Usual Lipid Emulsion Dosing On Bilirubin Neurotoxicity And Neurodevelopmental Impairment In Extremely Preterm Infants: Study Protocol For A Randomized Controlled Trial, Lindsay F Holzapfel, Cody Arnold, Jon E Tyson, Steven M Shapiro, Eric W Reynolds, Claudia Pedroza, Emily K Stephens, Alan Kleinfeld, Andrew H Huber, Matthew A Rysavy, Maria Del Mar Romero Lopez, Amir M Khan
Faculty, Staff and Student Publications
BACKGROUND: Bilirubin neurotoxicity (BN) occurs in premature infants at lower total serum bilirubin levels than term infants and causes neurodevelopmental impairment. Usual dose lipid infusions in preterm infants may increase free fatty acids sufficiently to cause bilirubin displacement from albumin, increasing passage of unbound bilirubin (UB) into the brain leading to BN and neurodevelopmental impairment not reliably identifiable in infancy. These risks may be influenced by whether cycled or continuous phototherapy is used to control bilirubin levels.
OBJECTIVE: To assess differences in wave V latency measured by brainstem auditory evoked responses (BAER) at 34-36 weeks gestational age in infants born …
Phase Ii Trial Of Medi0457 And Durvalumab For Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers, Van K Morris, Amir Jazaeri, Shannon N Westin, Curtis Pettaway, Solly George, Ryan W Huey, Michaela Grinsfelder, Aaron Shafer, Benny Johnson, David Vining, Ming Guo, Bryan Fellman, Michael Frumovitz
Phase Ii Trial Of Medi0457 And Durvalumab For Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers, Van K Morris, Amir Jazaeri, Shannon N Westin, Curtis Pettaway, Solly George, Ryan W Huey, Michaela Grinsfelder, Aaron Shafer, Benny Johnson, David Vining, Ming Guo, Bryan Fellman, Michael Frumovitz
Faculty, Staff and Student Publications
BACKGROUND: Human papillomavirus (HPV) types 16/18 drive oncogenesis for most patients with cervical, anal, and penile cancers. MEDI0457, a therapeutic DNA vaccine containing plasmids for E6 and E7 HPV-16/18 viral oncogenes and IL-12 adjuvant, is safe and provokes an immune response against E6/E7. We tested MEDI0457 with the anti-PD-L1 antibody durvalumab for patients with HPV-associated cancers.
METHODS: Patients with recurrent/metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated (anal and penile) cancers were eligible. Prior immune checkpoint inhibition was not permitted. Patients received MEDI0457 7 mg intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg …